ReShape Lap-Band® 2.0, FLEX & Access Port, Large D-3306

GUDID 00850007764555

ReShape Lap-Band® 2.0, FLEX & Access Port, Large

Reshape Lifesciences Inc.

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• Primary Device ID: 00850007764555
• NIH Device Record Key: 2bd942ab-4be0-4dfe-a28e-3b7567d94750
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReShape Lap-Band® 2.0, FLEX & Access Port, Large
• Version Model Number: D-3306
• Catalog Number: D-3306
• Company DUNS: 022894714
• Company Name: Reshape Lifesciences Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com
• Phone: 844-937-7374
• Email: CustomerService@ReShapelifesci.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged and consult instructions for use

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007764555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000008

FDA Product Code

• LTI: Implant, Intragastric For Morbid Obesity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-30
• Device Publish Date: 2024-01-22

Devices Manufactured by Reshape Lifesciences Inc.

• 00850007764500 - ReShape Lap-Band® 2.0 FLEX, Standard: 2024-01-30 ReShape Lap-Band® 2.0 FLEX, Standard
• 00850007764517 - ReShape Lap-Band® 2.0 FLEX, Large: 2024-01-30 ReShape Lap-Band® 2.0 FLEX, Large
• 00850007764548 - ReShape Lap-Band® 2.0, FLEX & Access Port, Standard: 2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard
• 00850007764555 - ReShape Lap-Band® 2.0, FLEX & Access Port, Large: 2024-01-30ReShape Lap-Band® 2.0, FLEX & Access Port, Large
• 00850007764555 - ReShape Lap-Band® 2.0, FLEX & Access Port, Large: 2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Large
• 00850007764586 - ReShape Lap-Band® 2.0, FLEX Tubing Kit: 2024-01-30 ReShape Lap-Band® 2.0, FLEX Tubing Kit
• 00850007764258 - ReShape Calibration Tubes: 2023-03-24 Calibration and Sizing Tube 32 French
• 00850007764265 - ReShape Calibration Tubes: 2023-03-24 Calibration and Sizing Tube 36 French
• 00850007764272 - ReShape Calibration Tubes: 2023-03-24 Calibration and Sizing Tube 40 French